Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease

November 21, 2018 updated by: Steven J. Hardy
Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD). These deficits can significantly disrupt otherwise normal trajectories toward academic and vocational achievement and negatively impact psychosocial outcomes. Despite widespread recognition of neurocognitive deficits, there are no treatments shown to maintain or recover functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been a standard intervention used to stabilize and recover functioning in individuals with accidental or disease-related brain injury. Recent advances in technology have led to the development of computerized CT programs. This study seeks to assess the feasibility and efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed). Feasibility will be assessed by examining participation, retention, and program completion rates, as well as feedback from a feasibility and acceptability questionnaire and a brief qualitative interview. Participants will also complete assessments of attention, working memory, and academic fluency at baseline and immediately following the intervention. A final assessment will be conducted 6 months after the conclusion of the intervention to evaluate the stability of treatment effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with sickle cell disease (HbSS, HbSC, or HbS-beta thalassemia).
  • 7 to 16 years old.
  • An absolute or relative working memory deficit.
  • IQ of 70 or greater, as measured via the WISC-V.
  • Presence of a caregiver who is willing and capable of providing consistent support and supervision during Cogmed training.

Exclusion Criteria:

  • Visual, motor, or auditory impairment that prevents computer use.
  • Insufficient English fluency.
  • Started taking or adjusted dose of medication to treat symptoms of ADHD in the last 30 days.
  • Unreliable access to a source of electricity to charge an iPad battery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cogmed intervention
Cogmed RM Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed)
Behavioral: Cogmed RM
Cogmed consists of 12 increasingly challenging exercises (completed over 25 sessions spanning 5-8 weeks) that target skills involving visuo-spatial and verbal working memory.
Experimental: Cogmed-waitlist control
Cogmed RM Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed)
Behavioral: Cogmed RM
Cogmed consists of 12 increasingly challenging exercises (completed over 25 sessions spanning 5-8 weeks) that target skills involving visuo-spatial and verbal working memory.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cogmed feasibility assessed by program completion rates
Time Frame: Following completion of Cogmed (approximately 8-10 weeks from baseline)
Feasibility will be determined by examining the proportion of the sample that completes at least 20 Cogmed sessions (i.e., 80% of the program) within the allotted time frame (10-week maximum).
Following completion of Cogmed (approximately 8-10 weeks from baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Digit Span subtest
Time Frame: Baseline, 8-10 weeks, 6-month follow-up
Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Digit Span subtest after completing Cogmed.
Baseline, 8-10 weeks, 6-month follow-up
Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Picture Span subtest
Time Frame: Baseline, 8-10 weeks, 6-month follow-up
Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Picture Span subtest after completing Cogmed.
Baseline, 8-10 weeks, 6-month follow-up
Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Spatial Span subtest
Time Frame: Baseline, 8-10 weeks, 6-month follow-up
Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Spatial Span subtest after completing Cogmed.
Baseline, 8-10 weeks, 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steven J. Hardy

Investigators

  • Principal Investigator: Steven Hardy, PhD, Children's National Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

November 23, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00004421
  • 2013141 (Other Grant/Funding Number: Doris Duke Charitable Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anemia, Sickle Cell

Clinical Trials on Cogmed RM

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe